A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer
A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer
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DOI：
10.1016/j.radonc.2015.02.014
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发表时间：
2015-03-01
影响因子：
5.7
通讯作者：
Yu, Jinming
中科院分区：
文献类型：
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作者：
Zhao, Hanxi;Xie, Peng;Yu, Jinming
背景：急性放射性食管炎（ARIE）是胸部放疗并发的主要毒性反应之一，严重影响患者的生活质量和放疗的进行。目前还很难快速治愈。我们的I期试验初步表明，EGCG可能是治疗ARIE的一种有前景的策略。 材料和方法：我们前瞻性地招募了2013年1月至2014年9月来自中国山东省肿瘤医院八十二研究所的III期肺癌患者。所有患者均接受同步或序贯放化疗，或仅接受放疗。 ARIE 出现后即给予 EGCG。放疗期间及放疗后两周给予EGCG，浓度为440μmol/L。每周记录RTOG评分、吞咽困难和食管炎相关疼痛。结果：37例IIIA和IIIB期肺癌患者纳入本试验。与原来相比，EGCG处方后第1、2、3、4、5周以及放疗后第1、2周的RTOG评分显着下降（P分别为0.002、0.000、0.000、0.001、0.102、0.000、0.000）。每周疼痛评分均显着低于基线（P分别为0.000、0.000、0.000、0.000、0.006、0.000、0.000）。结论：本试验证实口服EGCG是治疗ARIE的有效且安全的方法。 III期随机对照试验有望进一步证实EGCG在ARIE治疗中的效果。 (c) 2015 Elsevier Ireland Ltd. 保留所有权利。
Background: Acute radiation-induced esophagitis (ARIE) is one of main toxicities complicated by thoracic radiotherapy, influencing patients' quality of life and radiotherapy proceeding seriously. It is difficult to be cured rapidly so far. Our phase I trial preliminarily showed that EGCG may be a promising strategy in the treatment of ARIE.Materials and methods: We prospectively enrolled patients with stage III lung cancer from the Shandong Tumor Hospital 82 Institute in China from January 2013 to September 2014. All patients received concurrent or sequential chemo-radiotherapy, or radiotherapy only. EGCG was administrated once ARIE appeared. EGCG was given with the concentration of 440 mu mol/L during radiotherapy and additionally two weeks after radiotherapy. RTOG score, dysphagia and pain related to esophagitis were recorded every week.Results: Thirty-seven patients with stage IIIA and IIIB lung cancer were enrolled in this trial. In comparison to the original, the RTOG score in the 1st, 2nd, 3rd, 4th, 5th week after EGCG prescription and the 1st, 2nd week after radiotherapy decreased significantly (P = 0.002, 0.000, 0.000, 0.001, 0.102, 0.000, 0.000, respectively). The pain score of each week was significantly lower than the baseline (P = 0.000, 0.000, 0.000, 0.000, 0.006, 0.000, 0.000, respectively).Conclusion: This trial confirmed that the oral administration of EGCG is an effective and safe method to deal with ARIE. A phase III randomized controlled trial is expected to further corroborate the consequence of EGCG in ARIE treatment. (c) 2015 Elsevier Ireland Ltd. All rights reserved.